Quality Engineer I
Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Quality Engineer I
Title:Quality Engineer I
Quality Engineer I - Worcester, MA
Responsibilities and Authority
Under the direction of the Quality Manager, the Quality Engineer I will:
- Lead by example and promote the criticality of strict company compliance adherence
- Assist in the training of personnel, including customers and suppliers on workmanship and quality standards.
- Assure all outgoing product is manufactured in a compliant manner.
- Support process qualification/validation and new product introduction processes.
- Development and execution of Control Plans.
- Review device history records for quality approval as needed.
- Under direction of the Quality Manager, oversee and execute Redline and Engineering Change Notifications (ECN’s) processing. Collaborate with Project Managers (PM’s) to analyze customer ECN’s and ensure effective implementation to the production floor through proper use of the company Engineering Change Order (ECO) process, including reviewing and communicating impacts of any changes (e.g., financial, inventory, WIP, open supplier orders, etc.).
- Suggest improvements to ECN/ECO process that lead to improved efficiency, accuracy, and quality.
- Meet or exceed established ECO implementation performance metrics.
Non-Conformances, Complaints, CAPAs
- Drive improvement of company Quality through analyzing non-conformances (NC’s) and performing root cause analysis of discrepancies. Propose, review and implement approved corrective and preventive actions
- Collaborate with all internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs using various techniques including but not limited to Reenactment, PFMEA, Control Plans, Five Whys, Ishikawa (fishbone) Diagrams, Pareto Analysis, etc.
- Support non-conforming material issues resolution with suppliers.
- Collaborate with customer to help determine root cause of customer issues.
- Lead the Quality Control inspection process
- Develop skills as a Trainer to new QC Inspection resources.
- Development of quality and inspection plans.
- Under direction of the Quality Manager, Assist in develop and execute supplier audit plans.
- Contribute to the ongoing assessment of current and new potential suppliers.
- Support continuous supplier improvement through collection of data and performing statistical analysis.
- Continually build strong rapport with customers and supplies through data collection and metrics generation.
- Promptly respond to manufacturing floor quality issues, taking appropriate action within the company Quality System.
- Work with Manufacturing Engineers, assembly, production and test to identify trends and propose and implement corrective actions.
- Collaborate with PM’s to develop optimal work order routings.
- Collaborate with Supply Chain, PM’s and Operations on managing the Material Review Board (MRB) process.
- Positive attitude, self-motivator, and tenacious follow up required.
- Superior customer service attitude.
- Excellent teamwork, communication, and interpersonal skills.
- Bachelor’s degree, preferably in a science or engineering discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements.
- Strong electro-mechanical orientation.
- Experience in ISO-13485 certified required and cGMP organizations preferred.
- Minimum of 2 years professional experience in medical subassembly and finished device manufacturing. 3 to 5 years preferred. Significant and applicable professional experience may be considered in lieu of medical device requirements.
- Proven problem solver.
- Knowledge of IPC 610 and 620 standards beneficial.
- Advanced Level Skills in MS Word and Excel such as keyboard short cuts, creating macros and forms, table techniques, working with images and text, pivot tables.
- Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross functional flow charts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable.
- Standing for prolonged periods of time
- Lifting up to 30 pounds
- Maintenance Multi-Craft Day Shift in Gainesville GA
- Maintenance Technician in Lawrenceville GA
- Customer Service Rep in Needham Heights MA
- Receptionist in Alpharetta GA
- Outside Account Manager in Brooklyn Park MN
- NDT Level III Inspector in Santa Fe Springs CA
- NDT Level II Inspector in Santa Fe Springs CA
- Quality Control Inspector in Cumming GA
- Assembler - Kitter in Milford MA
- Mechanical Drafter in Brooklyn Park MN
- Solidworks Drafter in McBee SC
- IT Recruiter MA in Woburn MA
- Electrical Engineer in Alpharetta GA
- Manufacturing Engineer in Pendergrass GA
- 2nd Shift Machine Operator in Newton MA
- Collections Specialist in Norwell MA
- Financial Analyst in Milford MA
- Inventory Controller in Lebanon NH
- Shipper in Plymouth MA
- Sr. Assembly Technician in East Boston MA
- CAD designer in Hudson MA
- Welder in Duluth GA
- Safety Engineer in Norcross GA
- Material Handler in Taunton MA
- Manufacturing Supply Chain Clerk in Doraville GA
- Shipping in Duluth GA
- Mechanical Packaging Engineer in Ayer MA
- Shipping & Receiving Clerk in Norwood MA
- Manufacturing Lab Technician in Norwood MA
- Maintenance Planner in Gainesville GA
- Engineering Intern in Memphis TN
- Order Processor in Duluth GA
- Planner in Duluth GA
- Depot Repair Technician in Duluth GA
- Receiving Material Handler in Flowery Branch GA
- Warehouse in Suwanee GA
- Deployment Team in Suwanee GA
- Assembler in Acton MA
- Technical Recruiter MA in Marlborough MA
- QA Technician in Lawrence MA
- ID-OD GRIND MACHINIST in Santa Fe Springs CA
- Electromechanical Technician in Beverly MA
- Controls Engineer in Vance AL
- Electrical Design Engineer in Suwanee GA
- Wiring Technician in Suwanee GA
- Mechanical Design Engineer in Suwanee GA
- HR Director in MA
- CNC Machinist in Contoocook NH
- Sr. Electrical Designer in Alpharetta GA
- Quality Engineer in Minneapolis MN
- 2nd Shift Machine Operator in Plymouth MA
- 2nd shift ID-OD GRIND MACHINIST in Central Manchester CT
- Shipper- Warehouse Associate (seasonal) in Ashland MA
- Control Panel Power Wirer in Brooklyn Park MN
- Maintenance Controls Tech in Gainesville GA
- Electro-Mechanical Assembler - Technician in New Brighton MN
- Buyer in Milford NH
- Shipping Clerk in Brooklyn Park MN
- Bench Repair Technician in Cumming GA
- Welder - Sheet metal fabricator in N. Billerica MA
- Program Manager in Saint Petersburg FL
- electro-mechanical assemblers in Merrimack NH
- Standard Fabrication - 1st Shift in Suwanee GA
- Quality Engineer in Newnan GA
- Maintenance Mechanic in Lynn MA
- EM Assembler in Westborough MA
- Manufacturing Engineer in Chelmsford MA
- Quality Engineer in Maple Grove MN
- Packaging Supervisor in Lynn MA
- Technical Writer in Norwell MA
- Accountant in Loganville GA
- Assembly in Buford GA
- Wiring Technician in Buford GA
- Production Admin in Duluth GA
- Shift Supervisor in Duluth GA
- Maintenance Mechanic, Class A, 1st shift in Worcester MA
- Industrial Engineer in Loganville GA
- 2nd Shift Shipping Lead in Lynn MA
- Quality Engineer in Clinton MA
- Assembly Technician in Tucker GA
- Assembler in Suwanee GA
- Press Brake Operator in Duluth GA
- Mechanical Engineer in Bedford MA
- Process Engineer in Covington GA
- Refrigeration Technician in Acton MA
- Electrical Technician in Milford MA
- Supplier Quality Technican in Milford MA
- Documentation Control Specialist in Maple Grove MN
- Clinical Data Manager in Boston MA
- Mechanical Assembler- 2nd Shift in Santa Fe Springs CA
- machinists- 2nd shift 3p-11 in Santa Fe Springs CA
- Programmer in Contoocook NH
- Quality Documentation Coordinator in Bloomington MN
- Lab Processing Clerk in Norwood MA
- Sr. Mechanical Engineer in Norwood MA
- Inside Sales Representative in Golden CO
- Microdeburrer in Milford MA
- Assembly Specialist in Milford MA
- Quality Assurance Technician in Maple Grove MN
- Lean Manager-Continuous Improvement Manager in Milford NH